CLINICAL TRIAL: PNEUMOCOCCAL VACCINE RESPONSE IN COPD

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 慢性阻塞性肺病（COPD）是一种影响许多吸烟者的肺部疾病。COPD患者发生细菌感染的风险增加，包括由一种名为肺炎链球菌（肺炎球菌）的细菌引起的感染。肺炎球菌可引起肺炎、脑膜炎、血液感染或COPD急性加重，这是一种肺部症状暂时恶化，可能需要住院治疗，并可能危及生命。目前，大多数公共卫生组织建议所有COPD患者以及65岁以上的任何人接种肺炎球菌疫苗。目前用于成人的疫苗是荚膜多糖（CPS）疫苗，由23种灭活的肺炎球菌制成。肺炎球菌有近100种，但这23种是成人感染的最常见原因。接种疫苗会使身体产生抗体，帮助抵抗由这23种肺炎球菌引起的肺炎球菌感染。尽管该疫苗已被证明可以预防年轻健康患者的感染，但它对老年患者和患有COPD等潜在医学问题的患者似乎不太有效。在过去的几年中，已经开发了一种称为蛋白结合疫苗（PCV）的新疫苗。与CPS疫苗一样，PCV也是由杀死的肺炎球菌制成的，但它也含有白喉毒素，这是一种似乎能增强人体免疫反应的物质。自2000年以来，该疫苗已用于2岁以下儿童，并已在成人中进行了测试。虽然PCV仅由7种类型的肺炎球菌制成，因此不能提供与CPS疫苗一样多的细菌保护，但70岁以上患者的一些研究表明，PCV疫苗的抗体反应可能优于CPS疫苗。美国食品和药物管理局批准的PCV疫苗在儿童中的剂量为0.5 mL，但似乎1.0 mL剂量可能对成人更有效。在这项研究中，我们将尝试找出1.0 mL PCV疫苗是否比CPS疫苗在中重度COPD患者中产生更好的免疫应答。这项研究由美国国立卫生研究院资助，由马里兰州大学医学院的Steven Scharf博士和美国其他九个研究机构的研究人员进行。我们计划在马里兰州大学招募约18名患者，在全国招募180名患者。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs that affects many smokers. Patients with COPD are at increased risk for bacterial infections including those caused by a kind of bacteria named Streptococcus pneumoniae (Pneumococcus). Pneumococcus can cause pneumonia, meningitis, infections of the blood, or COPD ¿exacerbations¿, a temporary worsening of lung symptoms that may require hospitalization and could be life-threatening. At present, most public health organizations recommend that all patients with COPD, as well as anybody over the age of 65, be vaccinated against pneumococcus. The vaccine currently used in adults is the capsular polysaccharide (CPS) vaccine which is made from 23 types of killed pneumococcus. There are almost 100 types of pneumococcus but these 23 are the most common causes of infections in adults. Giving the vaccine causes the body to make antibodies that help fight off pneumococcal infections caused by these 23 types of pneumococcus. Although the vaccine has been shown to prevent infections in young, healthy patients, it appears to be less effective in older patients and in those with underlying medical problems such as COPD. In the last several years, a new vaccine called the protein-conjugate vaccine (PCV) has been developed. Like the CPS vaccine, the PCV is also made from killed pneumococcus but it also contains diphtheria toxin, a substance that appears to increase the body¿s immune response. The vaccine has been used in children under the age of 2 since the year 2000 and has undergone testing in adults. Although the PCV is made from only 7 types of pneumococcus and therefore does not offer protection against as many bacteria as the CPS vaccine, some studies in patients over age 70 suggest that the antibody response to the PCV vaccine may be better than with the CPS vaccine. The Food and Drug Administration approved dose of the PCV vaccine in children is 0.5 mL but it appears that a 1.0 mL dose may work better in adults. In this study, we will try to find out whether 1.0 mL of the PCV vaccine gives a better immune response than the CPS vaccine in patients with moderate to severe COPD. The study is funded by The National Institutes of Health and is conducted by Dr. Steven Scharf from the University of Maryland School of Medicine and researchers from nine other research institutions in the United States. We plan to enroll about 18 patients at the University of Maryland, and 180 patients nationally.